Job Scope:

Operate and maintain equipment and the facility to ensure that our products are manufactured and delivered to the customer on time, made at the best cost, safely and above all to the required quality standards for sterile products, fully compliant to regulatory requirements, right first time according to the Quality Management System.

Job Responsibilities:

• To clean and disinfect cleanrooms in Production.
• To perform operation, changeover, cleaning, and housekeeping for manufacturing machines relevant in SVI (Small Volume Injectables) plant.
• To perform operation, changeover, cleaning, and housekeeping for manufacturing machines relevant in Biopharma Insulin and Vaccine plant as and when required.
• To perform cleaning and housekeeping, changeover, to assist sampling, calibration, operation, and breakdown maintenance for machines in Production.
• Assist in validation activities such as process validation, equipment qualification, and cleaning validation when required.
• To troubleshoot problems for production cleanroom.
• Assist in line clearance and in-process checks to ensure correct materials, labels, and equipment setup prior to production.
• To ensure and assist in the smooth running of production according to schedule and meet approved quality standard.
• To ensure that the manufacturing of products is according to BMR.
• To ensure that all process/activities are recorded in logbook/forms/BMR promptly and correctly as per GDP and GMP.
• To perform filter integrity testing.
• To assist in preventive maintenance of production equipment.
• Control of self and conduct especially in attendance, punctuality at work, compliance to company rules.
• Ensure that production department is capable of and reliably and repeatedly demonstrates that it delivers on time.
• To operate the machine to produce and store products according to the appropriate documentation in order to obtain the required quality.
• To meet plant hygiene requirements and standards of aseptic.
• Ensure that the workplace is safe place to work and use PPE at all the required workstation.
• Participate in training and skill development programs to ensure competency in cleanroom practices, aseptic techniques, and equipment handling.
• Perform material handling activities (e.g., receiving, verifying, staging, transferring materials to/from cleanroom) in compliance with GMP.
• Monitor and maintain cleanroom environmental conditions (temperature, humidity, pressure differentials, particle counts) by supporting Environmental Monitoring (EM) activities.
• Ensure proper segregation and disposal of production waste (e.g., biohazard, sharps, rejected materials) as per regulatory and safety procedures.
• Support audits and inspections by regulatory bodies, quality assurance, and third parties by ensuring readiness of area, documents, and practices.
• To achieve compliance with HALAL requirements, ISO requirements such as ISO 9001, ISO 14000, ISO 45001, ISO 17025, cGMP, and GDP requirements such as PIC/S, EU-GMP, local regulatory and third-party principal requirement.
• To undertake any other duties as directed by the Shift Leader/Team Leader and Management as and when required.

Job Qualifications:

• Minimum Diploma in related field.
• Knowledge and understanding of pharmaceutical hygiene and GMP.
• Knowledge and understanding of relevant health and safety requirements.
• Basic written and verbal command of English.
• Possess essential skills such as customer care, time management, teamwork, willingness to learn, work standards, written communication, discipline, need to achieve, tenacity, and spoken communication.